Head and neck cancer

Description Results NMA

OS 0.70 [0.51; 0.96] median 7.5 mo vs. 5.1 mo Demonstrated

PFS 0.89 [0.70; 1.13] median 2.0 mo vs. 2.3 mo

nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks (n=361)

vs.

standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). (n=0)

open-label

Parallel groups

Sample size: 361/0

Primary endpoint: overall survival

FU duration:

OS 0.81 [0.66; 0.99]

pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle (n=-9)

vs.

standard treatment (methotrexate, docetaxel or cetuximab) (n=-9)

open-design

Sample size: -9/-9

Primary endpoint: OS

FU duration:

Overall response (CR + PR) to induction CT 1.18 [1.05; 1.34]

Overall response (CR + PR) to study treatment 1.71 [1.36; 2.14]

Complete response to induction CT 2.47 [1.64; 3.73]

complete response to study treatment 1.75 [1.36; 2.25]

All grade 3 to 4 events during induction CT 0.90 [0.68; 1.20]

frebrile neutropenia (grade 3-4) during induction CT 1.63 [0.54; 4.90]

neutropenia (grade 3-4) during induction CT 1.05 [0.69; 1.59]

Toxic death during induction CT 0.51 [0.09; 2.75]

death (overall survival) 0.85 [0.69; 1.06]

progression or death (progression free survival) 1.00 [1.00; 1.00]

induction chemotherapy with paclitaxel, cisplatin, and fluorouracil (n=189)

vs.

induction chemotherapy with cisplatin and FU (n=193)

Open

Parallel groups

Sample size: 189/193

Primary endpoint: CR

FU duration: 1.93y (0.025-5y)